Clinical Trial: Rituximab in IgG4-related Disease: A Phase 1-2 Trial
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Rituximab in IgG4-Related Disease: A Phase 1-2 Trial
Brief Summary: The primary objective of this study is to evaluate the safety and effectiveness of rituximab in IgG4-RD.
Detailed Summary: This two-center trial will enroll at total of 30 patients with IgG4-RD. The two participating sites are the Massachusetts General Hospital (Boston, MA) and the Mayo Clinic (Rochester, MN). All patients will receive rituximab 1 gram intravenously times two doses, separated by approximately 15 days. The primary efficacy outcome - disease remission and successful completion of the glucocorticoid taper - will be assessed at six months. Patients will be followed on the protocol for an additional six months after measurement of the primary outcome.
Sponsor: Massachusetts General Hospital
Current Primary Outcome: Primary (Disease Response) [ Time Frame: Six months ]
Disease Response at six months is the primary endpoint in this trial. The ability to maintain disease remission off glucocorticoids is an important clinical measure in this disease.
Disease Response - Disease Response is defined at 6 months as:
- Improvement of > 2 points in the IgG4-RD RI over baseline
- No glucocorticoid or other immunosuppressive drug use between months 4 and 6
- No disease flares, as assessed by the IgG4-RD Responder Index.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Massachusetts General Hospital
Dates:
Date Received: April 22, 2012
Date Started: April 2012
Date Completion:
Last Updated: January 7, 2015
Last Verified: January 2015
